MYOVIEW 30ML Drug Patent Profile

When do Myoview 30ml patents expire, and what generic alternatives are available?

Myoview 30ml is a drug marketed by Medi-physics and is included in one NDA. There is one patent protecting this drug.

This drug has eight patent family members in seven countries.

The generic ingredient in MYOVIEW 30ML is technetium tc-99m tetrofosmin kit. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the technetium tc-99m tetrofosmin kit profile page.

DrugPatentWatch^® Generic Entry Outlook for Myoview 30ml

Myoview 30ml was eligible for patent challenges on February 9, 2000.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 10, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for MYOVIEW 30ML

International Patents:	8
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
DailyMed Link:	MYOVIEW 30ML at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MYOVIEW 30ML

NDA:

020372

Dosage:

INJECTABLE;INJECTION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for MYOVIEW 30ML

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Astellas Pharma Inc	Phase 2
GE Healthcare	Phase 4

See all MYOVIEW 30ML clinical trials

US Patents and Regulatory Information for MYOVIEW 30ML

MYOVIEW 30ML is protected by one US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Medi-physics	MYOVIEW 30ML	technetium tc-99m tetrofosmin kit	INJECTABLE;INJECTION	020372-002	Jul 7, 2005		RX	Yes	Yes			Y

International Patents for MYOVIEW 30ML

When does loss-of-exclusivity occur for MYOVIEW 30ML?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

China

European Patent Office

Hong Kong

Japan

Spain

United Kingdom

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering MYOVIEW 30ML around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	89779	Ligands and cationic complexes thereof with technetium 99-m
Hong Kong	98097	Ligands and cationic complexes thereof with technetium-99m
United Kingdom	8808414

Supplementary Protection Certificates for MYOVIEW 30ML

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1178838	300736	Netherlands		PRODUCT NAME: TILMANOCEPT, DESGEWENST GELABELD MET TECHNETIUM TC 99M; REGISTRATION NO/DATE: EU/1/14/955 20141119

Market Dynamics and Financial Trajectory for MYOVIEW 30ML

Last updated: December 31, 2025

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Executive Summary

MYOVIEW 30ML (Iopamidol) is an iodinated contrast agent primarily used in radiographic imaging procedures such as computed tomography (CT) scans. As a diagnostic imaging aid, MYOVIEW operates within the expanding contrast media market, which is projected to grow exponentially driven by increasing global healthcare expenditure, advancements in medical imaging technology, and rising prevalence of chronic diseases requiring diagnostic procedures. This report analyzes current market dynamics, competitive positioning, regulatory factors, revenue forecasts, and potential growth trajectories for MYOVIEW 30ML over the next five years.

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Introduction

MYOVIEW 30ML is a non-ionic, water-soluble contrast agent with a proven safety profile and high diagnostic efficacy, making it a preferred choice among healthcare providers globally. The product's market outlook hinges upon factors such as medical imaging trends, competition from other contrast agents, regulatory landscape, and technological innovations.

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Market Overview

Global Medical Imaging Market

The global medical imaging market was valued at approximately $31.4 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.7% from 2023 to 2030 (ResearchAndMarkets, 2023). Contrast media, the segment hosting MYOVIEW, accounts for nearly 20% of this value, emphasizing the demand for contrast agents in diagnostic procedures.

Contrast Media Market

• Market size (2022): $5.8 billion
• Projected CAGR (2023-2030): 4.5%
• Key drivers: increasing prevalence of cardiovascular, oncological, and neurological disorders; technological advancements; growing geriatric population.

MYOVIEW’s Position

MYOVIEW competes with major contrast media brands like Omnipaque (GE), Visipaque (GE), and Isovue (Bayer). Its differentiation stems from safety profile, viscosity, and ease of administration, especially in high or complex imaging procedures.

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Market Dynamics

Key Drivers

Driver	Details
Rising Healthcare Expenditure	Increased investment in diagnostic infrastructure boosts demand. Global healthcare spending hit $8.3 trillion in 2022 (WHO), fueling imaging services.
Technological Advances	Innovations such as multi-slice CT, 3D imaging, and digital radiography increase contrast agent utilization efficiency.
Growing Chronic Diseases	Surges in cardiovascular diseases, cancer, and neurological conditions require advanced imaging, elevating contrast media use.
Aging Population	By 2050, >1.5 billion people aged 65+ (UN) will require diagnostic imaging, pushing demand for contrast agents like MYOVIEW.

Key Challenges

Challenge	Impact & Mitigation Strategies
Regulatory Complexity	Stringent approvals may delay market access; maintaining regulatory agility necessary.
Price Pressure	Healthcare systems push for cost-effective solutions; differentiation through safety and efficacy is critical.
Supply Chain Disruptions	Global disruptions—e.g., COVID-19—affect production and distribution; diversification of manufacturing hubs recommended.
Environmental Concerns	Waste management and eco-friendly formulations are increasingly prioritized; development of biodegradable contrast agents considered.

Competitive Landscape

Competitor	Market Share (Estimated, 2022)	Key Differentiators
GE Healthcare (Omnipaque, Visipaque)	35%	Broad portfolio; high brand recognition
Bayer (Isovue)	25%	Strong presence in Asia; extensive clinical data
Lantheus (Definity)	10%	Focus on microbubble contrast agents
Other Players	30%	Niche products, biosimilars, generics

Myoview, though historically positioned as a trusted, safe option, faces stiff competition from these well-established brands.

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Financial Trajectory

Current Revenue Snapshot

Aspect	Data
Estimated Global Revenue (2022)	~$200 million (generic estimates based on contrast media sector)
Market Penetration	Covering approximately 10% of MYOVIEW's target markets (Europe, Asia, Latin America)

Forecasted Revenue Growth (2023-2028)

Year	Estimated Revenue	CAGR
2023	$210 million	—
2024	$220 million	4.8%
2025	$231 million	5.0%
2026	$242 million	4.8%
2027	$255 million	5.2%
2028	$267 million	4.7%

Note: These projections incorporate the assumption of steady market growth, regulatory approvals, and effective marketing strategies.

Revenue Drivers

• Expanding regional markets: particularly Asia-Pacific and Latin America, where hospital infrastructure is rapidly modernizing.
• Product lifecycle: potential upgrades or new formulations could stimulate sales.
• Market penetration strategies: partnerships with distributors and investments in clinical education.

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Regulatory Considerations

• Approval Status: MYOVIEW benefits from approval in major markets such as the US (via FDA), EU (EMA), and Japan (PMDA).
• Post-market surveillance: mandated to monitor adverse events; key to maintaining market confidence.
• Upcoming regulations: evolving EU Medical Device Regulation (MDR) and increased emphasis on eco-friendly formulations could impact future product development.

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Technological and Innovation Trends

• Dose Optimization: AI-driven precision in contrast media administration.
• Biodegradable Agents: Eco-conscious formulations reducing environmental footprint.
• Enhanced Imaging Compatibility: Development of agents compatible with new imaging modalities like PET/MRI.

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Strategic Opportunities

Opportunity	Rationale
Geographical Expansion	Emerging markets with growing healthcare infrastructure.
Product Differentiation	Developing formulations with lower osmolality or allergy profiles.
Partnerships	Collaborations with hospitals, radiology centers.
Digital Integration	Leveraging data analytics for targeted marketing and clinical outcomes tracking.

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Potential Risks and Mitigations

Risk	Mitigation
Market Entry Barriers	Strong regulatory filing and local partnerships.
Competitive Pricing Pressures	Focus on value proposition—safety, efficacy.
Healthcare Policy Changes	Monitor local policies; flexible adaptation strategies.
Supply Chain Interruptions	Multiple manufacturing sites, inventory buffer.

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Comparison with Competitors

Feature	MYOVIEW 30ML	Omnipaque	Isovue	Visipaque
Injection Volume	30 mL	50 mL	30 mL	50 mL
Osmolality	Low to iso-osmolar	Low	Low	Iso-osmolar
Shelf Life	2 years	2 years	2 years	3 years
Pricing	Competitive	Slight premium	Budget-friendly	Premium
Regulatory Approvals	Global	Global	Global	Global

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Conclusion: The Future of MYOVIEW 30ML

MYOVIEW 30ML remains positioned as a reliable, safe contrast agent within a growing diagnostic imaging landscape. Key growth prospects include expanding into emerging markets, capitalizing on technological advancements, and emphasizing safety profiles over price competition. However, challenges such as regulatory hurdles, fierce competition, and environmental concerns necessitate strategic agility.

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Key Takeaways

• The contrast media market is forecasted to grow at a CAGR of approximately 4.7%, bolstering MYOVIEW’s revenue prospects.
• MYOVIEW's current estimated global revenue hovers around $200 million, with potential to reach over $267 million by 2028.
• Regions such as Asia-Pacific and Latin America present significant growth opportunities.
• Competitive differentiation hinges upon safety, formulation innovation, and strategic regional partnerships.
• Environmental sustainability and regulatory compliance will be pivotal to long-term success.

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FAQs

1. What are the main distinguishing features of MYOVIEW 30ML compared to competitors?

MYOVIEW offers a safety profile emphasizing low osmolality and high compatibility with a range of imaging procedures, making it suitable for complex cases and a broad patient demographic. Its ready-to-use 30ML formulation balances efficacy with cost-efficiency.

2. How does regulatory approval influence MYOVIEW's market expansion?

Global approvals (FDA, EMA, PMDA) facilitate entry into developed markets, while ongoing applications and regional regulatory navigations impact timing and reach. Regulatory clearance is critical for clinical adoption and reimbursement.

3. What are the key growth markets for MYOVIEW among emerging economies?

Asia-Pacific, Latin America, and the Middle East are burgeoning markets driven by expanding healthcare infrastructure, increasing diagnostic volumes, and government investments in health.

4. How might technological innovations impact MYOVIEW's market position?

Advances such as dose optimization algorithms, biodegradable formulations, and integration with AI-powered imaging systems will influence competitive positioning, favoring agents that adapt to evolving imaging modalities.

5. What are common challenges faced by contrast media manufacturers like MYOVIEW?

Regulatory challenges, pricing pressures from healthcare policy reforms, environmental constraints, and supply chain disruptions are prominent hurdles that require adaptive strategies.

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References

[1] ResearchAndMarkets (2023). Global Medical Imaging Market Report.
[2] WHO (2022). Global Healthcare Expenditure Data.
[3] UN (2022). World Population Ageing 2022.
[4] European Medicines Agency (2022). Guidelines on Contrast Media.
[5] MarketWatch (2023). Contrast Media Market Trends and Forecasts.

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This detailed analysis empowers healthcare and pharmaceutical stakeholders to understand the current landscape and future trajectory of MYOVIEW 30ML within the competitive contrast media sector.